NCT06208657

Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Australian & New Zealand Children's Haematology/Oncology Group · Academic / Other
• Sex: All
• Age: 0 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

A companion platform trial to test novel targeted agents based on the patient's tumor profile.

Detailed description

Both Australia (Zero Childhood Cancer) and Canada (PROFYLE) have developed precision oncology programs for the pediatric population through which samples from childhood/adolescent cancers undergo in depth genetic profiling. OPTIMISE is a companion platform trial, which will link patients to novel targeted agents based on their tumor profile. The trial will have multiple basket arms based on the most common genetically altered pathways the investigators have identified in these childhood cancers. Each arm of the trial will be histopathology agnostic and test a rational, novel combination therapy, to maximise potential clinical benefit.

Conditions

• Childhood Cancer
• Childhood Solid Tumor
• Childhood Brain Tumor
• Recurrent Cancer
• Refractory Cancer

Interventions

Type	Name	Description
DRUG	Paxalisib	Paxalisib starting at 21mg/m2 oral, daily, 28 day cycle, 13 cycles.
DRUG	Opdualag	Opdualag, a fixed-dose combination of Nivolumab 480mg and Relatlimab 160mg, intravenous, on day 1, 28 day cycle, 26 cycles
DRUG	Irinotecan (drug)	Irinotecan starting at 50mg/m2/day, intravenous, on days 1-5, 28 day cycle, 13 cycles.
DRUG	Temozolomide (TMZ)	Temozolomide starting at 150mg/m2/day, oral, on days 1-5, 28 day cycle, 13 cycles.

Timeline

• Start date: 2024-07-10
• Primary completion: 2030-12-01
• Completion: 2035-12-01
• First posted: 2024-01-17
• Last updated: 2026-01-28

Locations

14 sites across 2 countries: Australia, Canada